POLY-TUSSIN DM- dextromethorphan hydrobromide, phenylephrine hydrochloride and chlorpheniramine maleate syrup 
Poly Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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POLY-TUSSIN DM

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)

Dextromethorphan Hydrobromide, USP...............................15 mg
Phenylephrine Hydrochloride, USP........................................5 mg
Chlorpheniramine Maleate, USP............................................2 mg

Purpose

Cough Suppressant, Nasal Decongestant, Antihistamine

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

Warnings

Do not exceed recommended dosage.

Do not use this product

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.  If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  These could be signs of a serious condition.
  • new symptoms occur

If pregnant or breast-feeding,

ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed 4 doses in a 24 hour period.
Adults and children
12 years of age and over:
2 teaspoonfuls (10 mL)
every 6 hours as needed.
Children 6 to under 12 years
of age:
1 teaspoonful (5 mL)
every 6 hours as needed.
Children 2 to under 6 years
of age:
Consult a physician.

Children under 2 years
of age:
Not recommended.


Other information

Store at controlled room temperature, 15° - 30° C (59° - 86°F).

Inactive ingredients

Citric Acid, FD and C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, and Strawberry Flavor.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number.  Call 1-800-882-1041
Mon-Fri (8 a.m. to 5 p.m. CST)

Manufactured for:
Poly Pharmaceuticals, Inc.
Mobile, AL  36619

Manufactured by:
Great Southern Laboratories
Houston, TX  77099

PRODUCT PACKAGING

The packaging below represents the labeling currently used.

Principal Display Panel and Side Panel for 473 mL Label:

NDC 50991-320-16

POLY-TUSSIN DM

COUGH SYRUP

Cough Suppressant
Nasal Decongestant
   Antihistamine

Sugar Free /  Alcohol Free

Strawberry Flavor

Each 5 mL (one teaspoonful) for oral admininstration
contains:
Dextromethorphan Hydrobromide, USP..................15 mg
Phenylephrine Hydrochloride, USP..........................5 mg
Chlorpheniramine Maleate, USP..............................2 mg

Distributed by:
Poly Pharmaceuticals, Inc.
Mobile, AL  36619

16 fluid ounces (473 mL)

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container with a child-resistant closure.

This bottle is not to be dispensed to the consumer.

Distributed by:  Poly Pharmaceuticals, Inc. Mobile, AL  36619

Iss. 12/09



Poly-Tussin DM Packaging



Poly-Tussin DM Packaging




POLY-TUSSIN  DM
dextromethorphan hydrobromide, phenylephrine hydrochloride, chlorpheniramine maleate syrup
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50991-320
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide15 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg  in 5 mL
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate2 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-320-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/21/2005
Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 3/2011
Document Id: c7720496-e9a6-4a60-ae62-413e258475b8
Set id: 7c7ce381-c668-4955-bab8-26ba1965a575
Version: 1
Effective Time: 20110304
 
Poly Pharmaceuticals, Inc.